NCT04339660

Clinical Research of Human Mesenchymal Stem Cells in the Treatment of COVID-19 Pneumonia

Status unknown Phase 1, PHASE2 Last updated 9 April 2020

What this trial tests

Phase 1, PHASE2 trial testing UC-MSCs in COVID-19 in 30 participants. Status unknown.

Timeline

1 February 2020

Primary endpoint
30 June 2020

30 June 2020

Quick facts

Lead sponsor	Puren Hospital Affiliated to Wuhan University of Science and Technology
Phase	Phase 1, PHASE2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	30
Start date	1 February 2020
Primary completion	30 June 2020
Estimated completion	30 June 2020
Sites	1 location across China

Drugs / interventions tested

• UC-MSCs — full drug profile →
• Placebo

Conditions studied

• COVID-19 — all drugs for COVID-19 →

Sponsor

Puren Hospital Affiliated to Wuhan University of Science and Technology

Who can join

Adults 18 to 75, any sex, with COVID-19. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The COVID-19 pneumonia has grown to be a global public health emergency since patients were first detected in Wuhan, China, in December 2019, which spread quickly to worldwide and presented a serious threat to public health. It is mainly characterized by fever, dry cough, shortness of breath and breathing difficulties. Some patients may develop into rapid and deadly respiratory system injury with overwhelming inflammation in the lung. Currently, no specific drugs or vaccines are available to cure the patients with COVID-19 pneumonia. Hence, there is a large unmet need for a safe and effective treatment for COVID-19 pneumonia patients, especially the critically ill cases. The significant clinical outcome and well tolerance was observed by the adoptive transfer of allogenic MSCs. We proposed that the adoptive transfer therapy of MSCs might be an ideal choice to be used. We expect to provide new options for the treatment of critically ill COVID-19 pneumonia patients and contribute to improving the quality of life of critically ill patients.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Challenges and advances in clinical applications of mesenchymal stromal cells.
   Zhou T, Yuan Z, Weng J, Pei D, et al · · 2021 · cited 489× · PMID 33579329 · DOI 10.1186/s13045-021-01037-x
2. COVID-19 and Cancer: a Comprehensive Review.
   Gosain R, Abdou Y, Singh A, Rana N, et al · · 2020 · cited 187× · PMID 32385672 · DOI 10.1007/s11912-020-00934-7
3. Mesenchymal stem/stromal cells as a valuable source for the treatment of immune-mediated disorders.
   Markov A, Thangavelu L, Aravindhan S, Zekiy AO, et al · · 2021 · cited 174× · PMID 33736695 · DOI 10.1186/s13287-021-02265-1
4. Mesenchymal stem cell treatment improves outcome of COVID-19 patients via multiple immunomodulatory mechanisms.
   Zhu R, Yan T, Feng Y, Liu Y, et al · · 2021 · cited 108× · PMID 34702946 · DOI 10.1038/s41422-021-00573-y
5. Potential therapeutic targets for combating SARS-CoV-2: Drug repurposing, clinical trials and recent advancements.
   Pandey A, Nikam AN, Shreya AB, Mutalik SP, et al · · 2020 · cited 80× · PMID 32497632 · DOI 10.1016/j.lfs.2020.117883
6. Emerging pharmacological therapies for ARDS: COVID-19 and beyond.
   Horie S, McNicholas B, Rezoagli E, Pham T, et al · · 2020 · cited 69× · PMID 32654006 · DOI 10.1007/s00134-020-06141-z
7. The mechanism underlying extrapulmonary complications of the coronavirus disease 2019 and its therapeutic implication.
   Ning Q, Wu D, Wang X, Xi D, et al · · 2022 · cited 64× · PMID 35197452 · DOI 10.1038/s41392-022-00907-1
8. Immune Response and COVID-19: A mirror image of Sepsis.
   López-Collazo E, Avendaño-Ortiz J, Martín-Quirós A, Aguirre LA. · · 2020 · cited 59× · PMID 32792851 · DOI 10.7150/ijbs.48400